UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A randomized controlled trial for the effectiveness of self-management education using structured self-monitoring of blood glucose in noninsulin-treated type 2 diabetes patients
Title of the study (Brief title)	Effectiveness of structured self-monitoring of blood glucose in noninsulin-treated type 2 diabetes patients(RCT)
Region	Japan

Condition
Condition	Type 2 diabetes
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effectiveness of self-management education using structured self-monitoring of blood glucose in noninsulin-treated type 2 diabetes patients
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change in HbA1c (after 6 months and 12 months from starting SMBG use)
Key secondary outcomes	1.Self-efficacy for health behavior 2.health and life habit 3.health literacy (after 6 months and 12 months from starting SMBG use)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Device,equipment
Interventions/Control_1	1.7-point SMBG(fasting, preprandial/2-h postprandial at meal time, bed time) on 3 consecutive days every two months and recording 2.Comments to results of SMBG from physicians and nurses in outpatient clinic
Interventions/Control_2	Usual diabetes self-management education
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	25 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1.type 2 diabetes> 1 years 2.HbA1c level 7-12%(NGSP) 3.Noninsulin treatment and nonincretin injection treatment 4.not routine use of SMBG 5.currently treated by diet, exercise, oral diabetes medication 6.able to complete self-reported questionnaires
Key exclusion criteria	1. type 1 diabetes 2. currently treated by dementia, psychosis, recent emotional trauma 3. used steroids more than 14 days within the last 3 months 4. treated with chemotherapy or radiation therapy 5. pregnant or breast feeding 6. had severe depression or other severe psychological conditions
Target sample size	150

Research contact person
Name of lead principal investigator	Mariko Shiramizu
Organization	Kanagawa University of Human Services
Division name	School of Nursing, Faculty of Health & Social Services
Address	1-10-1, Heisei-cho, Yokosuka, Kanagawa
TEL	046-828-2624
Email	shiramizu-m@kuhs.ac.jp

Public contact
Name of contact person	Mariko Shiramizu
Organization	Kanagawa University of Human Services
Division name	School of Nursing, Faculty of Health & Social Services
Address	1-10-1, Heisei-cho, Yokosuka, Kanagawa
TEL	046-828-2624
Homepage URL
Email	shiramizu-m@kuhs.ac.jp

Sponsor
Institute	Faculty of Health & Social Services, Kanagawa University of Human Services
Institute
Department

Funding Source
Organization	Grants-in-Aid for Scientific Research, Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	済生会横浜市南部病院（神奈川県）、川崎市立川崎病院（神奈川県）、川崎市立井田病院（神奈川県）

Other administrative information
Date of disclosure of the study information	2014 Year 12 Month 22 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 09 Month 24 Day
Anticipated trial start date	2014 Year 12 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	This was a randomized controlled study to assess the effectiveness of structured self-monitoring of blood glucose testing among noninsulin-treated type 2 diabetes patients. Patients were recruited and randomized to a control group (CG) with usual care or a structured testing group (STG) at least every other month use of structured self-monitoring of blood glucose (SMBG). STG patients were trained to use a paper tool to collect 7-point glucose profiles over 3 consecutive days. The primary end point was HbA1c level measured at 6 months. The 6-month median HbA1c (IQR) of STG group was 7.2% and that of CG group was 7.6%; there was no statistically significant deference between them. Only the STG group showed significant reductions of median HbA1c from 7.5% to 7.2%.
Other related information

Management information
Registered date	2014 Year 12 Month 20 Day
Last modified on	2017 Year 06 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018618